MedPath

Registry based randomized study of Beta blocker, ACE Inhibitor and Angiotensin Receptor Blocker in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA-BAT)

Phase 1
Conditions
Myocardial infarction with non-obstructive coronary artery disease (MINOCA).
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2018-000889-11-NO
Lead Sponsor
Department of Medical Sciences, Akademiska sjukhuset
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
3500
Inclusion Criteria

1.Age >18 years.
2.A clinical diagnosis of MINOCA within the last 30 days.
3.Left ventricular ejection fraction =40% measured with echocardiography, MRI or left ventriculography during hospitalization and prior to randomization.
4.Written informed consent obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Any condition that may influence the patient's ability to comply with study protocol.
2.Previous revascularization (CABG or PCI)
3.Clinical signs of heart failure
4.MRI-proven myocarditis or a strong clinical suspicion of myocarditis as cause of the index event
5.Contraindications for beta-blockade
6.Contraindications for ACEI and ARB
7.Prior use of ACE-I, ARB, or beta blockers, which must continue according to treating physician.
8.New indication for beta-blockade or ACEI/ARB other than as secondary prevention according the investigator
9.Ongoing pregnancy or woman of childbearing potential not using highly effective contraceptives
9.Participation in a trial evaluating a drug known to interact with beta blockers or ACEI/ARB

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath